First clinical experience with a new-sensor-based navigation system to facilitate CRT implantation

Background: Cardiac resynchronization therapy (CRT) device implantation can be challenging, time consuming and fluoroscopy intense. To facilitate left ventricular (LV) lead placement, a novel sensor-based electromagnetic tracking system (MediGuide [MG], St. Jude Medical) has been developed. Purpose: To report the results of the First Human Use (FHU) study evaluating the feasibility, safety, and performance of a novel CRT implantation approach using MG-enabled operation equipment. Methods: Fifteen consecutive patients (66±8 years, 53% male) with an established indication for CRT were implanted using the MG tracking technology. Demographics, anatomical information, detailed fluoroscopy need, procedure time, and adverse events were collected. Patients were followed for 4 weeks after implantation. Results: The CRT system was successfully implanted with a lateral or posterolateral LV lead position in all patients. The total procedure time was 116±43 minutes, the median total fluoroscopy time (skin to skin) 5.2 (IQR 3.0 - 8.4) minutes, and the median fluoroscopy time for LV lead deployment (CS cannulation to withdrawl of CS sheath) measured 2.6 (IQR 1.6 - 5.6) minutes. There were no severe complications that required an acute intervention or re-operation during the peri- and postoperative period. ![Figure][1] Conclusions: Use of the MG tracking technology allows for safe and successful CRT implantation with an indication for substantially reduced fluoroscopy time. Future randomized studies are needed to validate these data. [1]: pending:yes